Evaluation of the Quality of Publications on Randomized Clinical Trials Using the Consolidated Standards of Reporting Trials (CONSORT) Statement Guidelines in a Spanish Tertiary Hospital
Evaluation of the Quality of Publications on Randomized Clinical Trials Using the Consolidated Standards of Reporting Trials (CONSORT) Statement Guidelines in a Spanish Tertiary Hospital
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DOI：
10.1177/0091270011407916
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发表时间：
2012-07-01
影响因子：
2.9
通讯作者：
Morcillo, Esteban
中科院分区：
文献类型：
--
作者：
Dasi, Francisco;Mercedes Navarro-Garcia, Maria;Morcillo, Esteban
进行临床试验（CT）的主要原因是测试药物或医疗程序的效果，以改善疾病的治疗。如果严格开展CT，并充分公布结果，CT的贡献最大。本研究的目的是使用CONSORT声明指南评估在三级医院进行的已完成CT的报告质量，以确定文章的哪些部分需要改进。通过检索MEDLINE和科克伦图书馆确定2002年至2008年发表的CT。发表了127份完成的CT中的40份。随着时间的推移，发表CT的文章数量和期刊质量显著增加。虽然这些文章发表在高影响力索引期刊上，但报告文章质量的综合标准（CONSORT）评分差异很大，这表明它们应该得到改善。标题、摘要、介绍和讨论部分获得了最高的CONSORT分数，几乎不需要改进。观察到对方法细节的报告以及对局限性和优势的讨论不足。总之，CT报告的质量仍有待提高，以便对已发表的试验进行可靠的质量评估。
The main reason for conducting a clinical trial (CT) is to test the effect of a drug or medical procedure to improve treatment of a disease. CTs contribute most when they are rigorously conducted and the results are published adequately. The aim of this study is to assess, using the CONSORT statement guidelines, the quality of reporting of completed CTs conducted at a tertiary hospital to determine which sections of the articles should be improved. CTs published between 2002 and 2008 were identified by searching the MEDLINE and Cochrane Library. Forty of 127 completed CTs were published. There was a marked increase in the number of articles and the quality of the journals that published the CTs over time. Although the articles were published in high-impact index journals, the Consolidated Standards of Reporting Trials (CONSORT) score reporting quality of the articles varied substantially, which indicates that they should be improved. The title, abstract, introduction, and discussion sections received the highest CONSORT scores and need little improvement. Poor reporting of methodological details and discussion on limitations and strengths were observed. In conclusion, much improvement remains to be made in the quality of reporting of CTs to allow reliable quality assessment of published trials.